| Sustaining competitive advantage within
| |
| | GreekCzech Republic - CzechEstonia -
|
| the medical device industry involves a
| |
| | EstonianHungary - HungarianLatvia
|
| global product strategy that recognizes
| |
| | - LatvianLithuania -
|
| the European market's substantial global
| |
| | LithuanianMalta - English &
|
| market share. Estimated at 30% of the
| |
| | MaltesePoland - PolishRomania
|
| global medical device market, the
| |
| | - RomanianSlovakia - SlovakSlovenia
|
| European community poses increasing
| |
| | - SlovenianTurkey -
|
| regulatory challenges for medical device
| |
| | TurkishEU Member State Official Languages
|
| manufacturers. Regulations controlling
| |
| | Depending on the extent of the product's
|
| the manufacturing, marketing and usage of
| |
| | presence in the European Union, there are
|
| medical devices in the EU are forcing
| |
| | currently up to 12 languages required for
|
| manufacturers to incorporate language
| |
| | the labeling, IFUs, documentation, and
|
| translation and localization into global
| |
| | marketing materials in accordance with
|
| development strategies as individual
| |
| | the IVDD and MDD necessary for CE mark as
|
| Member States demand product information
| |
| | displayed in TABLE I .As the EU continues
|
| in the language of the local user.An
| |
| | to grow and the trading barriers
|
| exigent regulatory hurdle facing the
| |
| | dissolve, prospective Member States are
|
| medical device industry is the European
| |
| | actively transitioning regulations to
|
| Union's IVDD 98/79/EC directive which
| |
| | meet the CE mark criteria, requiring new
|
| went into effect December 7, 2003.
| |
| | languages. A midday regulatory shadow to
|
| Formulated five years ago, the IVDD 98/79
| |
| | the EU, European Free Trade Association
|
| EC dictates that as of the December date,
| |
| | (EFTA) countries of Iceland,
|
| all new in vitro medical devices must
| |
| | Liechtenstein and Norway are aggressively
|
| bear CE Marks or face refusal into the
| |
| | enforcing the CE mark, shown in TABLE II
|
| European market or regulatory, criminal
| |
| | . Although not a member of the EFTA,
|
| or product/civil liability.What is the
| |
| | Switzerland is also enforcing medical
|
| guiding principle behind the new
| |
| | device CE mark.In addition to the EFTA,
|
| directive?The IVDD Directive virtually
| |
| | 13 more countries have applied for
|
| eliminates the costly regulations imposed
| |
| | membership in the European Union.
|
| by individual member states.
| |
| | Performing a parallel migration to the
|
| Manufacturers who comply with the
| |
| | European Union's regulatory requirements,
|
| Directive will be able to apply the CE
| |
| | several of these future Member States are
|
| mark to their products and market them
| |
| | actively adopting the CE Mark to ensure
|
| freely within member states of the EU.
| |
| | goods can freely move throughout the
|
| The IVDD (In Vitro Diagnostic Devices
| |
| | European Union, including Poland,
|
| Directive) is one of three associated
| |
| | Romania, Slovakia, and Turkey, seeTABLE
|
| directives issued by the European Union,
| |
| | III .
|
| which together cover all forms of medical
| |
| | Global Harmonization and International
|
| equipment with the intent to ensure that
| |
| | Quality Standards
|
| only safe and effective products are sold
| |
| | In 1998, the United States and the
|
| in the European market. The directives
| |
| | European Union introduced the New
|
| clearly outline regulations regarding
| |
| | Transatlantic Agreement (NTA) to improve
|
| manufacturing, importing, and marketing
| |
| | economic cooperation between the two
|
| of such devices. The IVDD specifically
| |
| | economic powers. In this landmark accord
|
| involves in vitro ( in an artificial
| |
| | resides the Mutual Recognition Agreement
|
| environment outside the living organism )
| |
| | (MRA) that acknowledges the regulatory
|
| medical devices that examine human fluids
| |
| | standards of the respective economic
|
| or tissue samples to identify, diagnose,
| |
| | bodies-an area of transition that affects
|
| and monitor medical conditions. The IVDD
| |
| | the medical device industry. The European
|
| 98/79/EC brings in vitro devices in line
| |
| | Union medical device directives refer to
|
| with other medical devices already
| |
| | ISO 9001 as the series of quality
|
| regulated by the EU, the MDD (Medical
| |
| | management standards and the US refers to
|
| Devices Directive) and the AIMDD (Active
| |
| | FDA's Quality System Requirements and all
|
| Implantable Medical Devices
| |
| | corresponding good manufacturing (GMP)
|
| Directive).The IVDD and it sibling
| |
| | practices regulations. Benefiting medical
|
| directives apply progressive regulatory
| |
| | and pharmaceutical companies, both
|
| requirements to medical devices and their
| |
| | quality systems have made considerable
|
| accessories depending on the classified
| |
| | efforts to synchronize their requirements
|
| risk they present to the user, defined in
| |
| | further increasing the common ground
|
| the directive as Class I through III.
| |
| | between quality systems in North America
|
| Unless the classified product is a
| |
| | and Europe.ISO (International
|
| low-risk Class I device that does not
| |
| | Organization for Standardization)
|
| contain any sterile packaging or a
| |
| | Adding to the pressure the current ISO
|
| measuring function, manufacturers require
| |
| | 9000:1994 standard is transitioning to a
|
| a third-party Notified Body to
| |
| | new ISO: 9000:2000 series effective
|
| independently certify the device's
| |
| | December 14th of this year. However, as
|
| compliance to the Directive's Essential
| |
| | of May 15, 2003, only 19.5% of the total
|
| Requirements (a.k.a. Annex I)-good faith
| |
| | ISO registered North American companies
|
| is not enough. Additionally, in a new
| |
| | had completed their registration process.
|
| twist within the Directive, the
| |
| | This is essential in the entire chain of
|
| authorized representative shown on the
| |
| | requirements. The new standard is a
|
| device label for Class I devices
| |
| | consolidation of ISO 9001 and 9002, and
|
| manufactured outside the EU may be
| |
| | has more of a customer satisfaction and
|
| required to produce the technical file,
| |
| | continuous improvement focus not present
|
| including copies of all translated
| |
| | in previous versions.GMP (Good
|
| materials. Any incorrect labeling or
| |
| | Manufacturing Practices)
|
| instructions for use may lead to
| |
| | In December 1978, the FDA Good
|
| regulatory criminal or product/civil
| |
| | Manufacturing Practices (GMP) Regulation
|
| liability in the EU.Any medical device
| |
| | became effective, establishing Quality
|
| manufacturer wishing to market its
| |
| | System Requirements for products
|
| products in the European Union is fully
| |
| | regulated under the FDA, including
|
| responsible for complying with the
| |
| | medical devices. In 1990, the Safe
|
| corresponding safety and administrative
| |
| | Medical Devices Act (SMDA) expanded the
|
| Essential Requirements and must display
| |
| | GMP to include design, manufacturing,
|
| the CE mark of conformity as stated in
| |
| | packaging, labeling, storage,
|
| Article 16 of the IVDD 98/79/EC . If
| |
| | installation and servicing of all
|
| that's not a red flag, consider the next
| |
| | finished medical devices.Exporting
|
| regulatory deadline facing in vitro
| |
| | American Medical Devices
|
| device manufacturers: By December 7,
| |
| | Any medical device in the US market may
|
| 2005, the European Union will not only
| |
| | not be legally exported anywhere in the
|
| require a CE mark to legally market a
| |
| | world without prior FDA notification or
|
| product, but will require a CE mark to
| |
| | approval; however, for a device to be
|
| legally put a medical device into
| |
| | legally distributed in the US, the FDA
|
| service-a requirement much more critical
| |
| | requires:
|
| to the revenue of manufacturers and
| |
| | Registration of both the medical device
|
| healthcare!CE Mark: A passport to the
| |
| | and manufacturing site- Authorization for
|
| European Union
| |
| | commercial distribution through either a
|
| An abbreviation of a French phase
| |
| | 510(k) pre-market notification or a
|
| "Conformite Europeene," the CE mark
| |
| | Pre-market Approval (PMA) application
|
| indicates that the medical device
| |
| | depending upon the classification of the
|
| manufacturer has conformed to all the
| |
| | device- Compliance with FDA labeling
|
| obligations set forth by the Directive 98
| |
| | requirements- Manufacturing compliance
|
| 79/EC of the European Parliament.
| |
| | with the FDA's GoodManufacturing
|
| Affixing this multinational standardized
| |
| | Practices (GMP)While the FDA does not
|
| mark to a product will allow any global
| |
| | place any restrictions on the export of
|
| manufacturer a "passport" to freely
| |
| | these devices, certain countries require
|
| distribute their products within the
| |
| | an Export Certificate that the
|
| European Union without additional quality
| |
| | manufacturer and its devices are indeed
|
| testing or approvals. Reflective of the
| |
| | in compliance with FDA regulations.
|
| 1946 Treaty of Rome, the CE mark is a
| |
| | Medical devices that do not have a
|
| conformity tool that is intended to
| |
| | 510(k), PMA, or are solely manufactured
|
| further promote the establishment of a
| |
| | for export may by approved for
|
| single market where the free movement of
| |
| | exportation by the FDA through Section
|
| goods, persons, services and capital are
| |
| | 801(e)(1) of the FFDCA; however, the
|
| ensured. Fundamentally, the CE mark and
| |
| | manufacturer may experience regulatory
|
| the medical device directives remove many
| |
| | difficulties depending on the individual
|
| regulatory hurdles while providing
| |
| | country's requirements of an FDA Export
|
| stronger regulations for smaller
| |
| | Certificate, which, as stated above,
|
| countries; however, it also creates
| |
| | require a 510 (k) or a PMA.Sorting
|
| critical language compliance issues that
| |
| | through the regulations to achieve global
|
| may prove to be costly for manufacturers.
| |
| | product delivery
|
| Regardless of the intended global
| |
| | The question facing medical device
|
| harmonization, participating countries
| |
| | manufacturers in the current global
|
| are preserving their national cultures
| |
| | market is how to meet all language
|
| and languages by requiring product
| |
| | requirements in the most cost-effective,
|
| information in their own local
| |
| | regulatory compliant manner. Managing
|
| languages.IVDD, MDD & AIMD...more
| |
| | regulations and translations are among
|
| languages!
| |
| | the most critical aspects of developing
|
| Depending on device classification, to
| |
| | and marketing products for the life
|
| legally display the CE mark, the IVDD,
| |
| | sciences industries. Any mistake, no
|
| MDD, and AIMD all mandate that
| |
| | matter how minor, can delay product
|
| manufacturers provide all labeling,
| |
| | approvals, launches, or cause widespread
|
| information for usage, documentation, and
| |
| | public relations disasters. Therefore,
|
| marketing materials in the official
| |
| | developing translation and localization
|
| language(s) of the end-user's Member
| |
| | processes has become a competitive
|
| State, taking into account the training
| |
| | advantage for global manufacturers of
|
| and knowledge of the potential users as
| |
| | medical devices.Working closely with a
|
| stated in Article 4, Paragraph 4, IVDD 98
| |
| | translation and localization vendor who
|
| 79/EC .Documentation Translation
| |
| | specializes in medical language services
|
| Requirements - Conformity Assessment
| |
| | is an important step in conquering the
|
| Procedures
| |
| | ever-changing international regulatory
|
| Manufacturers are required to translate
| |
| | process. The choice of the translation
|
| the documentation relating to the
| |
| | provider is extremely important to ensure
|
| production, testing and quality processes
| |
| | that translations are accurate,
|
| in the official language(s) of the Member
| |
| | consistent and technically correct, as
|
| State in which the procedures are carried
| |
| | well as harmonious with the
|
| out as stated in Article 9, Paragraph 11
| |
| | manufacturers' processes.Medical language
|
| of the IVDD 98/79/EC. Depending on device
| |
| | service providers should-at the very
|
| classification, these documents must
| |
| | least-provide documented processes that
|
| include a number of required disclosures
| |
| | involve native-speaking linguists that
|
| dependent on the product classification.
| |
| | have expertise in both medical
|
| Depending on marketing and distribution
| |
| | translation and the medical industry. To
|
| objectives, some products may require up
| |
| | deliver consistency, quality and reduced
|
| to 12 languages, creating complicated
| |
| | costs, the language service provider
|
| multilingual product labeling and IFU
| |
| | should also implement terminology
|
| challenges. There can be over 20
| |
| | management tools and computer-assisted
|
| information pieces required for each
| |
| | translation solutions in concert with the
|
| product label of IFU, depending on the
| |
| | team of human translators.Conclusion
|
| classification as detailed in Annex I,
| |
| | Complex and ever-changing international
|
| Part B, Section 8 of the Directive.Table
| |
| | regulations controlling the marketing and
|
| I
| |
| | usage of medical devices are forcing
|
| Official Language(s) of EU Member
| |
| | manufacturers to incorporate language
|
| StatesMember State Official
| |
| | translation and localization into global
|
| language(s)Austria - GermanBelgium -
| |
| | development strategies. The European
|
| Dutch, French & GermanDenmark -
| |
| | Union members currently require that all
|
| DanishFinland - FinnishFrance
| |
| | product information be in the official
|
| - FrenchGermany - GermanGreece
| |
| | language of the local users and the
|
| - GreekIreland - EnglishItaly
| |
| | diversity of this economic area is only
|
| - ItalianLuxembourg - French,
| |
| | growing to include more regulations and
|
| German, LuxembourgishNetherlands -
| |
| | official languages. A simultaneous global
|
| DutchPortugal - PortugueseSpain
| |
| | release of medical devices involving up
|
| - SpanishSweden -
| |
| | to 12 languages in Europe alone makes
|
| SwedishUnited Kingdom - EnglishTable
| |
| | this issue as critical as the intended
|
| II
| |
| | purpose of the medical device.
|
| Official Language(s) of EFTA Member
| |
| | Medical device manufacturers can
|
| States
| |
| | cost-effectively market their products
|
| Member State Official language(s)Iceland
| |
| | globally while satisfying international
|
| - IcelandicLiechtenstein -
| |
| | regulatory requirements by partnering
|
| GermanNorway -
| |
| | with Net-Translators a qualified language
|
| NorwegianSwitzerland - German, French
| |
| | service provider in the very early stages
|
| & Italian( Switzerland is not a EFTA
| |
| | of product development. The right
|
| member but requires translation)Table III
| |
| | language partner can turn what may now
|
| Official Language(s) of Member States
| |
| | appear as a chaos of regulatory
|
| Applying For EU Membership
| |
| | requirements into a successful
|
| Member State Official language(s)
| |
| | international product release.
|
| Bulgaria - BulgarianCyprus -
| |
| |
|
